B-Care5

GUDID 04033817900726

LivaNova Deutschland GmbH

Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type Cardiopulmonary bypass system, roller type

Primary Device ID	04033817900726
NIH Device Record Key	f77154b1-6bb1-48b3-896d-3e6d82090070
Commercial Distribution Status	In Commercial Distribution
Brand Name	B-Care5
Version Model Number	Sensor Module (venous)
Company DUNS	343225272
Company Name	LivaNova Deutschland GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04033817900726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K092463

FDA Product Code

DTQ	CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2024-05-07
Device Publish Date	2015-10-16

On-Brand Devices [B-Care5]

04033817901075	Venous Sensor (complete)
04033817900726	Sensor Module (venous)